Purpose.This
funding opportunity announcement (FOA) issued by the National Cancer Institute
(NCI) is designed to extend the Cancer Disparities
Research Partnership (CDRP) program into its second (and final) implementation
stage. This limited competition FOA solicits applications for NIH U54
cooperative agreement awards from the five current recipients of the CDRP
Cooperative Agreement Planning Grants (U56). The CDRP U56 awardees represent
community-based institutions serving a larger fraction of generally medically
underserved, low-income, ethnic and minority populations than most other
healthcare institutions. Still, community-based institutions have not been
proportionately involved in NCI-sponsored research initiatives pertinent to these
underserved populations. The U56-based CDRP program had built the necessary clinical
research infrastructure to support the development of partnerships between the
awardees and their associated mentor cancer centers, which are actively
involved in accrual of patient populations into NCI-supported cancer clinical
trials. The transition to the U54 status under this FOA is expected to enable
the CDRP sites to maximize the access, accrual, and participation of their
targeted minority/underserved populations into NCI-sponsored clinical trials in
cancer control, prevention, and treatment.

Mechanism of Support. This FOA will utilize
the National Institutes of Health (NIH)
cooperative agreement specialized center (U54) award mechanism.

Funds Available and Anticipated
Number of Awards. The NCI intends
to commit up to approximately $2.55 million in total costs in FY2009 and up to a
total of $9.3 million over a 5-year period to support up to 3-5 awards.

Budget
and Project Period.Because the nature and scope of the proposed research
will vary from application to application, it is anticipated that the size and
duration of each award will also vary. The total amount awarded and the number
of awards will depend upon the quality, duration, and costs of the applications
received and the availability of funds.

Eligible
Institutions/Organizations. The only eligible organizations are the current recipients of the CDRP U56 cooperative agreement
planning award.

Eligible Project
Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources
necessary to carry out the proposed research are invited to work with their
institution/organization to develop an application for support. Individuals
from underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support.

Number
of PDs/PIs. Only
one PD/PI may be designated on the application.

Number
of Applications. Each current CDRP U56 awardee may submit one application.

Resubmissions.Resubmission
applications are not permitted in response to this FOA.

Renewals. Since this FOA
involves a change in the mechanism, all applications submitted in
response to this FOA will be considered new applications.

This funding
opportunity announcement (FOA) issued by the National Cancer Institute (NCI) is
designed to extend the Cancer Disparities
Research Partnership (CDRP) program into its second (and final) implementation
stage. This limited competition FOA solicits applications for U54 cooperative
agreement awards from the five current recipients of the CDRP Cooperative
Agreement Planning Grants (U56). The CDRP U56 awardees represent
community-based institutions serving a larger fraction of generally medically
underserved, low-income, ethnic and minority populations than most other
healthcare institutions. Still, community-based institutions have not been
proportionately involved in NCI-sponsored research initiatives pertinent to
these underserved populations. The U56-based CDRP program had built the
necessary clinical research infrastructure to support the development of
partnerships between the awardees and their associated mentor cancer centers,
which are actively involved in accrual of patient populations into
NCI-supported cancer clinical trials. The transition to the U54 status under
this FOA is expected to enable the CDRP sites to maximize the access, accrual,
and participation of their targeted minority/underserved populations into
NCI-sponsored clinical trials in cancer control, prevention, and treatment.

This FOA is intended to: (a) support transition
of some of these pilot CDRP programs from a U56 planning phase into a U54
implementation phase; (b) enable the pilot CDRP sites at
community-based institutions to maximize the access and participation of their
targeted minority/underserved populations into NCI-sponsored clinical trials in
cancer control, prevention, and treatment. The overall goal of this new U54
CDRP program is to: (a) provide and expand the necessary clinical
research infrastructure, training outreach and patient navigation and research
collaborative capabilities; and (b) to increase minority/underserved patient
accrual into NCI-supported cancer prevention, symptom management, and
medical/surgical/radiation treatment trials. It is anticipated that, by the end
of this second funding period, the impacts made by the CDRP program participants
would insure their sustainability by securing additional non-NIH funding for
addressing cancer health disparities in targeted communities.

Background

Since the
enactment of the National Cancer Act in 1971, advances in cancer detection,
prevention, and treatment have led to a steady decline in the cancer-related deaths.
However, disparities in cancer incidence and mortality still exist as functions
of gender, ethnicity, and socioeconomic statuses. Men are about 50% more likely
than women to die from cancer. The incidences of colon and rectum cancers and of
lung and bronchus cancers in Alaska Natives and African American men and women are
significantly higher compared with the incidences in other ethnic groups. The death
rate from prostate cancer among African-American men is almost twice that in
white males. The incidence of cervical cancer in the Hispanic population has
been consistently higher at all ages, and African-American women have the
highest rate of deaths from cervical cancer. Five-year survival rates by
selected sites among populations experiencing the negative consequences of
health disparities in the United States (U.S.) (e.g., African Americans,
Asians, Pacific Islanders, Hispanics, Latinos, American Indians, Native Alaskans,
and/or those of low socioeconomic status) are lower than the 5-year survival
rates of the rest of the population.

Socioeconomic
status and cancer. Communities that are characterized by lower socioeconomic statuses
for their populations generally exhibit higher cancer death rates. The cancer
mortality rates for lung, trachea, bronchus, and pleura for minority males and
females differ widely when measured by state economic area. Examples of
geographical differences are seen in a pattern of excessive prostate cancer
among African American males in the Southeastern U.S., particularly in rural
areas. High rates of esophageal cancer in the District of Columbia and in the
Coastal area of South Carolina appear to be related to alcohol consumption,
tobacco use, and dietary deficiencies.

Risk
behaviors and cancer. The significant negative consequences of cancer-related health
disparities are also reflected in risk behaviors and health service
utilization. These include higher rates of smoking among some populations (e.g.,
American Indians), strikingly higher rates of obesity among African Americans
and Hispanics, and related dietary practices. Similarly, differentials have
been documented by age, income, education, and race/ethnicity in these health
practices as well as in cancer screening and treatment. Data confirm lower
rates of cancer screening and early detection, differential treatment patterns,
and greater frequency of a number of chronic diseases with similar risk
profiles to cancer. These and many other factors contribute to more advanced
disease at diagnosis, lower survival, and higher cancer death rates among
certain population groups.

Inadequate
access to healthcare and cancer. Due to a lack of screening and delays
in accessing adequate healthcare, underserved populations suffer
disproportionately from locally advanced cancers such as cancers of the cervix,
breast, lung, and head and neck, for which radiation therapy is the primary
treatment. Therefore, new pilot programs at community-based hospitals/institutions
are needed to develop new strategies/approaches to address these existing
cancer health disparities seen through the U.S.

Establishment
of the U56 CDRP program. The first stage of the CDRP program (which
was initiated in 2002) involved funding of Cooperative Agreement
Planning Grants (using the U56 funding mechanism). The goal
of that initiative was to get community-based hospitals/institutions to plan
and develop strategies for patient accrual to radiation oncology trials, and to
reduce the negative consequences of cancer disparities in underserved U.S. populations. The populations targeted by this first funding period for the CDRP (RFA-CA-03-018)
were those whose members accessed the health care system primarily when in the
advanced stages of their diseases. Because of these delays in obtaining
adequate healthcare, radiation oncology usually represents a major component of
the cancer treatment.

During
the first funding period, the six CDRP awardees used the U56 funding mechanism
to establish:

The clinical trial research infrastructure necessary at the
community-based institution so that members of their targeted ethnic/minority,
medically underserved or low income populations could participate in the latest
NCI-sponsored radiation oncology or combined modality treatment trials;

The necessary community education/outreach activities and patient
navigation program required before patient recruitment and accrual into
clinical trials could begin.

Main goals of the initial U56 funding
period. Since 2003, the CDRP U56 awards have allowed the awardees to plan,
develop, and implement their cancer disparity programs. Since the initial
objective/goal was to increase access and accrual of their targeted populations
into primarily radiation oncology focused clinical trials, it became evident
that due to the late stage of disease, co-morbidities, etc., the eligibility
criteria for accrual were often too restrictive for participation in existing
cooperative group clinical trials. In an effort to overcome this accrual
barrier at all of the CDRP sites, supplemental funds were earmarked from the NCI’s
Clinical Trial Working Group initiative to increase participation of minority/underserved
patients in NCI cancer clinical trials. This allowed an expansion into surgical
and medical oncology clinical trials for at least three CDRP sites, thus
boosting the trial availability for many more patients and higher accrual
rates.

Specific Research Objectives

Applications submitted in
response to this FOA must address all of the following objectives/goals of the
U54 implementation phase of the CDRP programs:

Establish and implement tracking mechanisms to determine screening,
eligibility and accrual rates for all cancer and disparity patients receiving
services at the CDRP sites;

Refine/modify the current clinical research infrastructure as necessary
to certify that the CDRP awardee institution will qualify to submit a
competitive application for funding as a Community Clinical Oncology Program
(CCOP) or a Minority-Based CCOP (MB-CCOP; http://prevention.cancer.gov/programs-resources/programs/ccop)
at the end of the next funding period;

Disseminate the experience gained and approaches used to build the
CDRP infrastructure and program to the public, targeting particularly other
disparities investigators. To maximize gains to others, this dissemination goal
should include sharing both successful and unsuccessful efforts. Plans for information
dissemination should include publication and presentation of findings and
results from ongoing U56 CDRP planning grant activities on various aspects, e.g.,
community outreach, patient navigation, barriers to recruitment and enrollment,
etc. In addition to individual institutional reports, collaborative
publications among CDRP awardees are encouraged to contrast and compare how
different strategies were applied. Plans for information dissemination should
include publication and presentation of findings and results from ongoing U56
CDRP planning grant activities on various aspects, e.g., community outreach,
patient navigation, barriers to recruitment and enrollment, etc.;

Participate in the ongoing formal program evaluation process conducted
by a current contract awarded to NOVA Research Company; and

Assume advocacy and leadership roles to assist disparities
populations in the U.S. become involved in NCI-supported cancer prevention,
screening, treatment, and other trials.

Main Requirements

All the CDRP U54 applicants must meet the main
requirements defined below.

1. The
applicant institution must have the necessary facilities to provide radiation
oncology services according to current standards, such as three-dimensional
treatment planning and computerized tomography (CT) simulation.

2. The
applicant institution must have a level of professional expertise that, at the
minimum, includes:

one board certified
radiation oncologist (to be designated as the PI)

another
investigator who is either a radiation, surgical, or medical oncologist who will
serve as a “back-up” to the PI and be capable of assuming the role
of PI in the event a change of PI is required

Physics
support at one or more full-time (40 hours) physicist at the Ph.D. or M.S.
level.

The PI and the
”back-up” PI are each expected to contribute at least 10% of
his/her time to the CDRP grant effort. A strong rationale must be provided (in the
budget justification) for commitment of less than 10%.

3. The
percentage of one or more of the target populations (e.g., African Americans,
Asians, Hispanics, Latinos, Native Americans, Alaskan Natives, Native
Hawaiians, Pacific Islanders and/or those with low socioeconomic status) which
is to be served by the applicant institution must be greater than the state average
of that population according to the 2000 U.S. Census Bureau statistics (http://www.census.gov/main/www/cen2000.html).
These populations must have a greater cancer incidence and/or mortality than
the national average according to NCI data (http://seer.cancer.gov). The
applicant institution must be a primary provider of care for the population
group(s) identified above according to the respective State Department of
Health statistics (http://apps.nccd.cdc.gov/uscs).

4. If
the applicant institution decides to continue the research collaborations with
the previously established research investigator institutions, he/she must
identify a mentor or consultant from each of the current and future research
collaborating institutions involved in their program.

NOTE: The existing relationships that applicants have with
their mentor institutions and collaborators under the initial CDRP planning
phase must now be converted into research collaborations during the U54
implementation phase. Any changes or additional new partnerships proposed for
the U54 partnership should be justified. These collaborating institutions can
be either an NCI-designated cancer center or a university-affiliated medical
center, health care institutions or freestanding cancer centers that are
accredited by:

This funding opportunity announcement (FOA)
will use the NIH Specialized
Center (U54) Cooperative Agreements award mechanism. The
applicant will be solely responsible for planning, directing, and executing the
proposed project.

This is a cooperative agreement award mechanism. In the cooperative agreement
mechanism, the Project Director/Principal Investigator (PD/PI) retains the
primary responsibility and dominant role for planning, directing, and executing
the proposed project, with NIH staff being substantially involved as a partner
with the Principal Investigator, as described under the Section
VI. 2. Administrative Requirements, "Cooperative Agreement Terms and
Conditions of Award."

This
FOA is a one-time solicitation and will not be reissued.

2. Funds Available

The NCI intends to commit approximately $2.55 million in
total costs in FY 09, and a total of $9.3 million over a 5-year period to
support three to five awards.Future
year amounts will depend on annual appropriations.

The
total project period for an application submitted in response to this FOA may
not exceed 5 years. An applicant may request a project period of up to
5 years with the annual budget requests gradually scaling down as follows. For
the first year of the project, the applicants may request a budget up to the level
of the final full year of their current CDRP U56 award. Because each CDRP site
is expected to work towards complete sustainability after the next funding
period, the applicants’ requested budgets for years 2 and 3 must
be reduced by 20% and then finally capped at $350,000 (total costs) for years 4
and 5, reflecting the basic funding required for maintenance of the clinical
trials research staff only.

Because the nature and scope of the proposed
research will vary from application to application, it is anticipated that the
size and duration of each award will also vary. Although the financial plans of
the NCI provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.

Facilities and administrative costs requested
by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.

A
nationally recognized accrediting body such as the American College of Radiology (http://www.acr.org/), either in the U.S. or in territories under U.S. jurisdiction.

Each
applicant CDRP institution may decide to continue their research collaborations
with their prior mentor institution/organization established during the U56
planning phase and/or establish new collaborations. Letters of Commitment from all
proposed U54 collaborators must be included in the application.

Applications must be prepared using the
current PHS 398 research grant application instructions and forms. Applications
must have a D&B Data Universal Numbering System (DUNS) number as the universal
identifier when applying for Federal grants or cooperative agreements. The
D&B number can be obtained by calling (866) 705-5711 or through the web
site at http://www.dnb.com/us/. The
D&B number should be entered on line 11 of the face page of the PHS 398
form.

The title and number of this funding opportunity must be typed in item (box) 2
only of the face page of the application form and the YES box must be checked.

Specific Guidelines and Modifications for Content of
Application. For the application submitted in response to this FOA, follow the standard instructions for the PHS 398 Research Plan (Items 2-5 as per Revision 11/07 of the PHS 398 Table of
Contents, previously known as “Sections A-D”), with the
following specifications and amendments:

Additional instructions for Items 4 and 5 of the PHS 398 Research
Plan are given below.

Other items of the PHS398 Research Plan remain unmodified.

Additional
Instructions for Items 4 and 5 of the PHS 398 Research Plan

Item 4: Preliminary Studies/Progress Report (up to 10 pages recommended).
The application must include a progress report, which must address progress made in achieving
the goals and objectives of the original CDRP application during the current
funding period. This section should include the following:

major
accomplishments under the U56 support;

description
of academic, clinical or research collaborations initiated as a result of NCI
CDRP funding, including mentor/partnerships activities;

description
of recruitment and retention of physicians, clinical research staff and other
key personnel in the program;

description
of Telesynergyâ telemedicine resource capabilities;

description
of established community and outreach activities;

patient
navigation program;

list
of abstracts or presentations at national meetings, such as those for RTOG, ASCO, ASTRO, etc.; and

list
of all publications and completed manuscripts resulting from the U56 grant,
providing URLs or PubMed Central submission identification numbers where
applicable.

provide
patient accrual numbers by minority status/ethnicity for each year of U56
support; indicate also the yearly number and percentage of
patients/participants who are: a) children; b) elderly; and c) underinsured/uninsured,
if known.

In addition, Item 4 must include the following elements:

Summary
of the social science/behavioral activities undertaken each fiscal year or
ongoing during the U56 support, including the rationale for the studies, the number of
participants involved and the results of these activities.

Summary
Table showing the number of active clinical protocols opened each fiscal year
since receipt of the CDRP award in each of the following categories: 1)
investigator-initiated (II); 2) radiation only (R); 3) surgical only (S),
medical only (M), or with radiation (RS/M); 4) cancer prevention (CP); 5)
cancer control/symptom management (CC); and 6) industry/pharmaceutical (P).
Indicate the new yearly accrual of patients to the different types of clinical
protocols.

Summary
of the clinical research infrastructure standard operating procedures the applicant institution
has established during the U56 grant period to recruit its targeted
minority/underserved population into NCI cancer clinical trials. A critical
requirement in the next funding period is the detailed tracking of screening,
eligibility, and accrual of patient population into clinical trials at each
CDRP awardee site. An example could be a diagrammatic flow chart of
activities/tasks involved along with designated personnel responsible for them
to justify requested personnel for next funding period.

Item 5: Research Design and Methods(up to 10 pages recommended).
This section will include research plans for the U54 grant period in the
following areas:

A. Clinical Research
Infrastructure – following an analysis of current CDRP program
for strengths and weaknesses, propose modifications to achieve the overall goal
of increasing accessibility and eligibility of targeted populations into NCI
cancer clinical trials, including but not limited to:

4) Research
with collaborating institution clinical trials, etc. The ultimate goal at the
end of next funding period is to acquire the capability to submit a competitive
application for funding as a Community Clinical Oncology Program (CCOP) or Minority-based
CCOP (http://prevention.cancer.gov/programs-resources/programs/ccop).

B. Investigator-Initiated
Clinical Protocols – Applicants considering the design of any
investigator-initiated clinical trial to be implemented during the U54 phase
must provide a plan for scientific evaluation of the validity and
appropriateness of the proposed trial before IRB submission.

C. Community Outreach
Activities and Patient Navigation Program – detailed description
of modifications, if any, to one or both components of the current CDRP program
to increase recruitment of targeted populations into NCI-supported cancer
clinical trials.

Letters of Commitment from all
proposed collaborating institutions/organizations must be included in the application.

Prospective
applicants are asked to submit a letter of intent that includes the following
information:

Descriptive title of proposed research;

Name, address, and telephone number of
the Principal Investigator;

Names of other key personnel;

Participating institutions; and

Number and title of this funding
opportunity.

Although a letter of
intent is not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows NCI staff to
estimate the potential review workload and plan the review.

Applications
must be prepared using the forms found in the PHS 398 instructions for
preparing a research grant application. Submit a signed, typewritten original
of the application, including the checklist, and three signed photocopies in one package to:

Applications must be received on or before the
application receipt date) described above (Section
IV.3.A.). If an application is received after that date, the application
may be delayed in the review process or not reviewed. Upon receipt, applications
will be evaluated for completeness by the CSR and for responsiveness by the
reviewing Institute Incomplete and/or non-responsive applications will not be
reviewed.

The NIH will not
accept any application in response to this funding opportunity that is essentially
the same as one currently pending initial review, unless the applicant
withdraws the pending application. However, when a previously unfunded
application, originally submitted as an investigator-initiated application, is
to be submitted in response to a funding opportunity, it is to be prepared as a
NEW application. That is, the application for the funding opportunity must not
include an Introduction describing the changes and improvements made, and the
text must not be marked to indicate the changes from the previous unfunded
version of the application.

All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at NIH Grants
Policy Statement.

Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the
beginning date of the initial budget period of a new or renewalaward if such costs: 1) are
necessary to conduct the project; and 2) would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new or renewalaward.

The incurrence
of pre-award costs in anticipation of a competing or non-competing award imposes
no obligation on NIH either to make the award or to increase the amount of the
approved budget if an award is made for less than the amount anticipated and is
inadequate to cover the pre-award costs incurred. NIH expects the grantee to be
fully aware that pre-award costs result in borrowing against future support and
that such borrowing must not impair the grantee's ability to accomplish the
project objectives in the approved time frame or in any way adversely affect
the conduct of the project (see the NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

6. Other Submission Requirements and Information

Awardees must agree to the "Cooperative
Agreement Terms and Conditions of Award" in Section VI.2.A "Award
Administration Information."

Representatives
of all recipients of CDRP U54 Cooperative Agreement Grant Awards will be
expected to participate in two Radiation Therapy Oncology Group (RTOG) meetings
and the annual American Society for Therapeutic Radiology and Oncology (ASTRO)
meeting, where the CDRP Program Steering Committee and Program Expert Committee
meetings, respectively, are held. Travel funds for this purpose should be budgeted
for in the grant application from the applicant institution.

The PI of each CDRP site and research group will
serve as a member of the CDRP Steering Committee, and will participate in
monthly conference calls. In addition, each CDRP awardee will present its
research findings at annual meetings of the steering committee and at no more
than three meetings per year. Funds for travel of the PIs and relevant staff to
these meetings should be included in the proposed budget.

Awardees must agree to the "Cooperative
Agreement Terms and Conditions of Award" in Section VI.2.A "Award
Administration Information."

Do not use the Appendix to circumvent the
page limitations of the Research Plan component. An application that does not
observe the required page limitations may be delayed in the review process.

Resource Sharing
Plan(s)

NIH
considers the sharing of unique research resources developed through
NIH-sponsored research an important means to enhance the value of, and advance
research. When resources have been developed with NIH funds and the associated
research-findings published or provided to NIH, it is important that they be
made readily available for research purposes to qualified individuals within
the scientific community. If the final data/resources
are not amenable to sharing, this must be explained in Resource Sharing section
of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(b) Sharing Model Organisms:
Regardless of the amount requested, all applications where the development of
model organisms is anticipated are expectedto include a
description of a specific plan for sharing and distributing unique model
organisms and related resources, or state appropriate reasons why such sharing
is restricted or not possible (see Sharing
Model Organisms Policy and NIH
Guide NOT-OD-04-042).

(c)
Genome-Wide Association Studies (GWAS): Regardless of the amount requested,
applicants seeking funding for a genome-wide association study are
expected to provide a plan for submission of GWAS data to the NIH-designatedGWAS data repository, or provide an appropriate explanation why
submission to the repository is not possible. A genome-wide association study
is defined as any study of genetic variation across the entire genome that is
designed to identify genetic associations with observable traits (such as blood
pressure or weight) or the presence or absence of a disease or condition. For
further information, see Policy for Sharing of Data Obtained in NIH Supported
or Conducted Genome-Wide Association Studies, NIH
Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application
Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review
criteria described below will be considered in the review process.

2. Review and Selection Process

Applications
that are complete and responsive to the FOA will be evaluated for scientific and
technical merit by an appropriate peer review group convened bythe National Cancer Instituteand in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.

As part of the scientific peer
review, all applications will:

Undergo
a selection process in which only those applications deemed to have the
highest scientific and technical merit, generally the top half of applications
under review, will be discussed and assigned a priority score;

Receive
a written critique; and

Receive
a second level of review by the National Cancer
Advisory Board.

The
following will be considered in making funding decisions:

Scientific
and technical merit of the proposed project as determined by peer review;

Availability
of funds; and

Relevance
of the proposed project to program priorities.

The
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, and weighted as
appropriate for each application. Note that an application does not need to be
strong in all categories to be judged likely to have major scientific impact
and thus deserve a meritorious priority score. For example, an investigator may
propose to carry out important work that by its nature is not innovative but is
essential to move a field forward.

Significance: Does this study address an important problem? If the
aims of the application are achieved, how will scientific knowledge or clinical
practice be advanced? What will be the effect of these studies on the concepts,
methods, technologies, treatments, services, or preventative interventions that
drive this field?

In addition, specific to
this FOA. Does this application address important
cancer-related health disparities problem(s) in their targeted population? In
particular, what has been and will be the effect of the proposed studies on addressing
cancer-related health disparities in their targeted population? If the aims of
the application are achieved, how will the proposed collaborative undertaking
advance scientific knowledge?

Approach: Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?

In addition, specific to
this FOA:

A. Progress Report:

Is
the feasibility of the proposed plans for the U54 application adequately
supported by the accomplishments made during the U56 planning phase?

Do
the activities and studies proposed appropriately address the strengths and
weaknesses identified during the U56 planning period?

Do
the mentor/partnership collaborations, community outreach and patient navigator
programs established during the U56 funding period reflect this program’s
potential for being successful in accruing their targeted population into NCI-supported
cancer clinical trials?

Does
the application adequately describe and provide the rationale for any studies
of attitudes, behavior, and beliefs undertaken in the targeted population with
regard to clinical trial participation?

Has
the applicant shown adequate progress in developing the clinical research
infrastructure at their hospital/institution/community to accrue patients to
radiation oncology or multimodality NCI-sponsored CTEP cancer clinical trials?

For
the applicants who designed and implemented their own investigator-initiated
radiation oncology clinical trials which address some specific barriers to
accrual, has accrual to these specific trials been completed, data analysis
done and results published? What is the progress to date for ongoing trials?

For
those applicants successful in receiving the NCI’s Clinical Trial Working
Group’s supplements for expanding minority/underserved patient accrual
into surgical and medical oncology clinical trials, has progress been
demonstrated to justify effective use of these funds?

Has
the applicant been successful during the current funding period in establishing
the mentor partnerships necessary to help develop and design their current CDRP
program to address cancer disparities in their targeted populations?

Has
the applicant been successful in developing the community outreach activities
and collaborations along with their patient navigator program in order to
establish the process necessary for recruitment of their targeted population
into NCI-supported cancer clinical trials?

Has
the applicant participated in programs to bring the CDRP program to the
attention of their local community and to the oncology community in general, including
presentations, publications, and targeted meetings?

B. Future Research
Plans. Has
the applicant analyzed the current CDRP program to determine areas of strengths
and weaknesses? Does their research plan adequately address/propose
implementation of new strategies or modification of current procedures for overall
improvement of program efficiency, effectiveness, and its likelihood for
sustainability and eventual application to become a CCOP or MB-CCOP at the end of the U54 phase?

Innovation: Is
the project original and innovative? For example: Does the project challenge
existing paradigms or clinical practice; address an innovative hypothesis or
critical barrier to progress in the field? Does the project develop or employ
novel concepts, approaches, methodologies, tools, or technologies for this
area?

Investigators: Are
the investigators appropriately trained and well suited to carry out this work?
Is the work proposed appropriate to the experience level of the principal
investigator and other researchers? Does the investigative team bring
complementary and integrated expertise to the project (if applicable)?

In addition, specific to
this FOA. Are
the qualifications and experience of the collaborating investigators adequate
to provide strong programmatic (e.g., scientific) and administrative
leadership? Are the qualifications and experience of other key personnel
of the applicant and the mentor partners adequate to successfully implement and
achieve the objectives of the U54 activities proposed? Do letters of commitment
from their research collaborators support the priorities and objectives of the
plan for the collaborative partnership?

Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Does the proposed work take advantage of the unique features of the
scientific environment or employ useful collaborative arrangements? How would
resource/infrastructure provide long-term stability to the activities of the
partnership? Is there evidence of institutional support?

Does the application
adequately describe the infrastructure for clinical research that was
established under the previous U56 award for patient participation in radiation
oncology, surgical and medical oncology clinical trials?

Does
the application adequately describe the resources available and necessary for
the success of the program (e.g., discretionary resources, space, faculty
positions, and protected time for research)?

In addition, specific to this FOA. Core Resources. Does the Telesynergy® telemedicine resource provided
in the U56 planning phase been effectively and efficiently used to support
their proposed research activities to achieve the goals of its application? Is
each specialized resource justified as essential for the conduct of proposed research?
Are the qualifications of the IT manager adequate?

2.A.
Additional Review Criteria

In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the rating:

Protection of Human Subjects from Research Risk: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed (see the Research Plan section on Human
Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated (see the Research Plan section on Human Subjects in the
PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five points described in the Vertebrate Animals
section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.

2.B. Additional Review
Considerations

Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.

2.C.
Resource Sharing Plan(s)

When relevant, reviewers will be instructed
to comment on the reasonableness of the following Resource Sharing Plans, or
the rationale for not sharing the following types of resources. However,
reviewers will not factor the proposed resource sharing plan(s) into the
determination of scientific merit or priority score, unless noted otherwise in
the FOA. Program staff within the NCI will be responsible for monitoring the
resource sharing.

Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award
costs. See Also Section IV.5. Funding Restrictions.

A
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official (designated in
item 12 on the Application Face Page). If a grantee is not email enabled, a
hard copy of the NoA will be mailed to the business official.

The following Terms and
Conditions will be incorporated into the award statement and will be provided
to the Principal Investigator as well as to the appropriate institutional
official, at the time of award.

2.A.
Cooperative Agreement Terms and Conditions of Award

The following special
terms of award are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when State and local Governments are eligible
to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and
funding instrument used for this program will be the cooperative agreement an
"assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial NIH programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and stimulate the recipients'
activities by involvement in and otherwise working jointly with the award
recipients in a partnership role; it is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this
concept, the dominant role and prime responsibility resides with the awardees
for the project as a whole, although specific tasks and activities may be
shared among the awardees and the NIH as defined below.

Throughout these Terms and Conditions of
Award, the Cancer Disparities Research Partnership (CDRP) refers to all individual CDRP awardees. All the awardee
institutions, principal investigators (PDs/PIs) and other key personnel (including
collaborating investigators and institutions) must agree to collaborate on the
goals of the CDRP Program and adhere to these Terms and Conditions of Award.

The PD/PI(s) will have
the primary responsibility to define objectives and approaches,
and to plan, conduct, analyze, and publish results, interpretations, and
conclusions of their studies. The PD/PI(s) assume(s)
responsibility and accountability to the applicant organization officials and
to the NCI for the performance and proper conduct of the NCI-CDRP program
supported by the U54 in accordance with these terms and conditions of the
award. The PI
and Co-investigators are expected to contribute at least 10% of his/her time to
the CDRP grant effort. A strong rationale must be provided (in budget
justification) for commitment of less than 10%.

Specific
rights and responsibilities will include the following:

Awardees have primary authorities and
responsibilities for the project as a whole, including defining objectives and
approaches, planning, implementing, clinical trials development, participant
recruitment and follow-up, data collection, quality control, interim data and
safety monitoring, analysis and interpretation, preparation of publications, as
well as collaboration with their partner and other awardees, and with
assistance from NCI Radiation Research Program (RRP) staff;

Each U54
research project awardee must designate one representative to serve as a voting
member on the NCI-CDRP Program Steering Committee (PSC). The representative
could be the PD/PI or another designated co-investigator. This representative
will have one vote;

All awardees must agree to abide by the decisions of the PSC. The PD/PI(s) of the U54 awards
will be responsible for accepting and implementing the goals, priorities,
procedures, and policies agreed upon by the PSC;

Awardees are responsible for
establishing an external advisory committee composed of experts not otherwise
associated with the activity;

Each CDRP awardee should conduct monthly meetings to discuss the progress and directions of its activities to insure that the necessary interactions are taking place;

The Principal Investigator, Co-Investigators,
and other designated investigators will attend an annual Program Expert
Committee meeting to be organized by NCI staff and held at the annual American
Society for Therapeutic Radiation Oncology (ASTRO) meeting;

The
CDRP awardee institutions shall work collaboratively with an evaluation
organization designated by the NIH/NCI (e.g., NOVA Research Company) to
facilitate evaluation of the program on an ongoing basis;

Each CDRP awardee will submit annual
progress reports to the NCI that describe the activities and accomplishments
during the previous funding period as part of the Non-Competing Continuation
Renewal; and

CDRP
awardees will retain custody of and have primary rights to the data and
software developed under these awards, subject to Government rights of access
consistent with current HHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

A designated
NCI Program Director acting as a Project Scientist will have substantial
programmatic involvement that is above and beyond the normal stewardship role
in awards, as described below. The NCI Project
Scientist will not attend peer review meetings of renewal (competing
continuation) and/or supplemental applications. If
such participation is essential, these individuals will seek NCI waiver
according to the NCI procedures for management of conflict of interest.

A Program
Official may also have substantial programmatic involvement (e.g., as
a Project Scientist or Coordinator). In that
case, the individual involved will not attend peer review meetings of renewal
(competing continuation) and/or supplemental applications, or will seek NCI
waiver.

The main NCI
responsibilities pertinent to CDRP program include the following activities:

The NCI Project Scientist will be a voting
member of the CDRP Program Steering Committee (PSC);

The NCI Project Scientist will work closely
with individual investigators and partners to facilitate successful
collaborations;

The NCI Project Scientist will provide
assistance in reviewing and commenting on all major transitional changes of the
awardee or partner institution’s activities prior to implementation to
assure consistency with the goals of this FOA;

The NCI Project Scientist will serve as
liaison between the PSC, the CDRP, and the NCI;

The NCI Project Scientist will provide
technical assistance and advice to the CDRP awardees and will facilitate and
coordinate their interactions with other NCI staff members and other NCI and
NIH programs, as needed;

The NCI Project Scientist will assist the PSC
in developing and drafting operating policies;

The NCI Project Scientist will notify the
Steering Committee of the NCI decisions regarding the funding of the CDRP
program;

The NCI Project Scientist will review the
scientific progress of individual CDRP U54 awardees, and the compliance of the
awardees with the operating policies developed by the PSC;

The NCI Project Scientist will monitor
institutional commitments and resources to ensure that the partnership receives
the maximum chance of stabilization and success;

The
NCI Project Scientist will help reprogram efforts, including options to modify
clinical research projects/programs when certain objectives of this FOA are not
met -- Specifically, the NCI Project Scientist may recommend withholding of support,
suspension, or termination of a U54 award for lack of adherence to policies
established by the PSC;

Working
together with PSC, the NCI Project Scientist will organize and make
final decisions on the agenda for an annual workshop that engages all of the
partnerships and other participants as needed. This meeting will be held for
all funded investigators to share progress and research insights that may
benefit all of the projects;

The
NCI Project Scientist will call additional meetings/workshops of
the participants to address emerging areas of high priority to the NCI and/or
the problems of high cancer incidence and mortality in populations experiencing
cancer disparities; and

The
NCI Project Scientist will facilitate formal program evaluation,
currently conducted by NOVA Research Company.

2.A.3. Collaborative Responsibilities

A.The Program Steering Committee (PSC). The
NCI Project Scientist and the PD/PIs of the CDRP awards will be responsible for
forming a Program Steering Committee (PSC), the main governing board of the
CDRP program. The PSC will make strategic decisions with regard to goals
and research implementation, including the establishment of shared resources
and the development of collaborations within the CDRP.

The PSC
will be composed of the following voting members: The designated PD/PI of
each CDRP program U54 awardee; a senior co-investigator from the collaborating
institutions; and, the NCI/RRP Project Scientist;

The PSC chairperson(s)
may not be an NCI representative;

The PSC’s recommendations, in the form
of a written annual report, are to be submitted to the PD/PI and
co-investigators at the collaborating institutions, the Board of Scientific
Advisors, sub-committees, and to the NCI;

One or more NCI-CDRP patient advocates will be included
as non-voting members of the PSC;

The PSC may establish sub-committees, as it deems
appropriate, such as a Program Expert Committee (PEC), which will
provide advice and make recommendations to the PSC, such as changing priorities
and directions or identifying areas of new opportunity. The PEC will be
composed of three members from the extramural community knowledgeable in cancer
disparities, and the RRP Program Director as an Ad Hoc member;

The NCI
Project Scientist will serve on sub-committees, as deemed appropriate;

The PSC may, when it deems it to be necessary, invite
additional, non-voting science advisors to the meetings -- The NCI reserves the
right to propose such additional candidates to augment the research or patient
advocate expertise of the CDRP program, when necessary; and

The PSC will meet twice every year at the summer and
winter RTOG meetings. Generally, an annual meeting of the
PSC, the PEC, the NCI/RRP Program Scientist, and other experts (as necessary),
will be held at the annual ASTRO meeting to review and discuss individual
progress and that of the overall CDRP Program.

2.A.4. Arbitration Process

Any
disagreements that may arise in scientific or programmatic matters (within the
scope of the award) between award recipients and the NIH may be brought to
arbitration. An Arbitration Panel composed of three members will be convened.
It will have three members: a designee of the Steering Committee chosen without
NIH staff voting, one NIH designee, and a third designee with expertise in the
relevant area who is chosen by the other two; in the case of individual
disagreement, the first member may be chosen by the individual awardee. This
special arbitration procedure in no way affects the awardee's right to appeal
an adverse action that is otherwise appealable in accordance with PHS
regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

Participation in the Program Steering Committee and other meetings;
and

Cooperative activities with the NCI.

A final progress report, invention statement,
and Financial Status Report are required when an award is relinquished when a
recipient changes institutions or when an award is terminated.

Section
VII. Agency Contacts

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research; peer review; and financial or grants
management issues:

Human Subjects Protection:Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.

Policy
for Genome-Wide Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/

Access
to Research Data through the Freedom of Information Act:The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided
guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Sharing of
Model Organisms:NIH is committed
to support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.

Inclusion of
Women And Minorities in Clinical Research:It is the policy
of the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a clear
and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43). All investigators proposing clinical research
should read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy continues
to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of
Children as Participants in Clinical Research:The NIH
maintains a policy that children (i.e., individuals under the age of 21) must
be included in all clinical research, conducted or supported by the NIH, unless
there are scientific and ethical reasons not to include them.

Required
Education on the Protection of Human Subject Participants:NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH applications for research involving human subjects
and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic
Stem Cells (hESC):Criteria for
federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.

NIH Public
Access Policy Requirement:In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.

Standards
for Privacy of Individually Identifiable Health Information:The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.

Healthy People 2010:The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not
subject to the intergovernmental review requirements of Executive Order 12372.
Awards are made under the authorization of Sections 301 and 405 of the Public
Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the
terms and conditions, cost principles, and other considerations described in
the NIH Grants Policy Statement. The NIH
Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent with
the PHS mission to protect and advance the physical and mental health of the
American people.

Loan Repayment Programs:NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.